Lorigerlimab

MacroGenics decided to “realign” its “pipeline priorities” when it came to lorigerlimab. \n Century Therapeutics, Candel Therapeutics and MacroGenics have all used their third-quarter earnings releases to disclose how they’re fine-tuning their clinical pipelines to conserve cash.Century has called time on the CALiPSO-1 trial of its allogeneic cell therapy CNTY-101 in patients with B cell-mediated autoimmune diseases. Five patients have already received the therapy in the trial, which has, so far, demonstrated a “favorable safety profile” with no dose-limiting toxicities or immune-effector-cell-associated neurotoxicity syndrome, according to the company.“The limited but emerging clinical data suggests encouraging clinical activity in refractory patient populations,” Century added.Still, the biotech has discontinued the trial as part of “clinical development re-prioritization efforts” that will see the company continue to assess CNTY-101 in the phase 1/2 Caramel trial, also for B-cell-mediated autoimmune disease.It was a similar story over at Candel, which is pausing the development of the off-the-shelf adenovirus immunotherapy called CAN-2409, also known as aglatimagene besadenovec, in borderline resectable pancreatic cancer (PDAC).The biotech acknowledged that the FDA had already granted fast track and orphan drug tags for CAN-2409 in this indication, but said it needed to pause the PDAC program in order to focus on its top priorities for CAN-2409 of prostate cancer and non-small cell lung cancer.CAN-2409 already completed a phase 3 trial in prostate cancer, and a midstage study in NSCLC is due to kick off in the second quarter of 2026.Candel said it will only reignite the PDAC program if it can source some “external, non-dilutive funding.” Meanwhile, MacroGenics decided to “realign” its “pipeline priorities” when it came to lorigerlimab. The company has been assessing the bispecific DART molecule, which targets both PD-1 and CTLA-4, in a phase 2 study of 150 patients with metastatic castration-resistant prostate cancer.A clinical update on that study had been expected in the second half of this year, but MacroGenics revealed in its earnings document that, after reviewing interim data from the study, “we have decided not to pursue further development of lorigerlimab in prostate cancer.”“Despite this decision, we remain committed to exploring lorigerlimab’s potential in ovarian and other gynecologic cancers and continue to enroll patients in the phase 2 LINNET study,” the company added.

Plus, news about Modulight Biotherapeutics, T-Therapeutics and EnGene: 🛑 MacroGenics cans PD-1xCTLA-4 bispecific in prostate cancer : The company said it would stop development of lorigerlimab in prostate cancer after looking at the interim data from a Phase 2 trial. The study was assessing the antibody on top of standard of care — chemo and steroids — in patients with metastatic castration-resistant prostate cancer. The drug remains in Phase 2 development in ovarian and other gynecologic cancers. Elsewhere, MacroGenics said it would receive $50 million from Sanofi and $25 million from Gilead before the end of the year. These are licensing payments: Sanofi has rights to the type 1 diabetes immunotherapy Tzield, which was recently approved in the UK and China. Gilead extended an existing deal with MacroGenics to include a preclinical program based on its novel T cell engager platform. — Elizabeth Cairns 🤝 Third Arc Bio taps Adagene for two T cell engagers: Third Arc, a biotech led by former J&J oncology head Peter Lebowitz, will pay Adagene $5 million upfront in a deal that comes with up to $840 million in milestones. The partners will develop two ‘masked’ T cell engagers, for which Third Arc will get global rights. However, Suzhou and San Diego-based Adagene will have the option to develop the drugs in  Greater China, Singapore and South Korea. — Lei Lei Wu 🌱 Modulight Biotherapeutics scores $12.2M in seed funding : The round was led by Jibe Ventures and LocalGlobe, and the cash will help speed the development of Modulight’s optogenetic technology as well as move its therapeutic pipeline towards the clinic. — Elizabeth Cairns 💰 T-Therapeutics extends Series A to $91M : The additional funding of $32 million comes from new investors Tencent and BGF, plus all of the biotech’s existing major shareholders. The company will spend the money on advancing its novel TCR-CD3 bispecifics in cancer and autoimmune disease. — Elizabeth Cairns 💰 EnGene raises $130M in share sale : The offering follows the release of more positive pivotal data on enGene’s bladder cancer gene therapy, which drove the biotech’s share price up 65%. — Elizabeth Cairns